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QA Manager (Manufacturing)

Job Description

To provide QA oversight of areas of the site and parts of the business as specified.   To be QA point of contact with the these areas for quality related issues to ensure that products are manufactured, stored, tested, released and distributed according to their defined specifications.  To manage your team as applicable, and maintain compliance with the relevant SOPs/regulations.

Responsibilities

  • Responsibility for provision of QA oversight of areas of the site and parts of the business as specified.

Develop relationship with cross functional departments as applicable through attendance at team meetings and area presence to ensure open communication and trust.

  • To manage your team accordingly. 

Manage all HR requirements of the team (holidays, sickness, timekeeping, end of year reviews and training planning).  To ensure that other team objectives are achieved and to monitor this progress, suggest and support execution of the work plan, suggest and implement improvements to it.

To support team development through coaching and feedback to encourage optimal performance.  To ensure mandatory training is in place and monitoring the training status of the team. 

  • To support the batch release process within QA.

Targeted resolution of quality issues for batches according to the planned release date.  This will also involve progression of deviations, change controls, CAPA and other elements of the quality systems accordingly.

  • To promote a Safety, Quality and cGMP culture in the team and across the site.

To ensure appropriate standards of cGMP, housekeeping, Health, Safety and Environment are applied in the team and site areas of responsibility, in accordance with current regulations and procedures. To be permanently inspection ready and prepared to participate as applicable.

  • To participate in improvement project/investigation teams where required.

Drive quality decisions and provide advice and technical support where required.  Coordinate completion of any resulting activities.  Demonstrate creative problem solving within cGMP constraints and align with best practice.

  • To perform training and attend relevant courses to maintain compliance status for own role..

To deputise for the manager for example in preparation for and running meetings. To escalate any areas of significant risk including both quality and personnel issues. Minimum Education Requirements

Bachelor’s degree in Science related subject or demonstration of equivalent.

Minimum Experience Requirements

Must have previous supervisory experience in a Pharmaceutical QA/QC role. Preferably with experience in Biologics.

About Us

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Company
CSL Plasma
Posted
11/20/2021
Salary Range
$73,000.00 - 121,000.00
per Year
Salary range estimated by
Location
Liverpool, NY 13090, US